Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Exactech® Alteon® HA Femoral Stem

K-Number: K162732 · 2017-04-26

ApplicantExactech, Inc.
Decision Date2017-04-26
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Exactech® Alteon® HA Femoral Stem is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2017-04-26 under 510(k) number K162732. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Exactech® Alteon® HA Femoral Stem?

Exactech® Alteon® HA Femoral Stem is a medical device that received FDA 510(k) clearance on 2017-04-26. The listed applicant is Exactech, Inc.. The 510(k) number is K162732.

When did Exactech® Alteon® HA Femoral Stem receive FDA 510(k) clearance?

Exactech® Alteon® HA Femoral Stem received FDA 510(k) clearance on 2017-04-26, under 510(k) number K162732.

Who is the listed applicant for Exactech® Alteon® HA Femoral Stem?

The FDA 510(k) record lists Exactech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Exactech® Alteon® HA Femoral Stem?

The FDA product code for Exactech® Alteon® HA Femoral Stem is MEH.

Other records listing Exactech, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260583Equinoxe® Shoulder SystemK250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsK243448Equinoxe® Shoulder SystemK243275Equinoxe® Scapula Fracture SystemK243839Alteon® HA Femoral StemsK240393Exactech® TRULIANT® Knee System

View all 41 devices →

Related Devices (Code: MEH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261576Icona Hip StemCorin, Ltd.K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KGK251166Mfinity Femoral SystemMedacta International S.A.K251052Trivicta® Hip StemOrtho Development Corp.K242315Resolve Modular Revision Hip StemUnited Orthopedic CorporationK243839Alteon® HA Femoral StemsExactech, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑